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Trial: NCT01001338 [RDF]

Label NCT01001338
Slug nct01001338
Trialid NCT01001338
Lookup name NCT01001338
Lastchanged date July 11, 2016
Firstreceived results date
Firstreceived date October 22, 2009
Id info nct id NCT01001338
Overall status Active, not recruiting
Id info secondary id
Biospec retention
Required header link text Link to the current record.
Enrollment 216
Number of arms 4
Is section 801 Yes
Is fda regulated Yes
Brief title Allopurinol Combination Study
Acronym RDEA594-203
Official title Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients With an Inadequate Hypouricemic Response With Standard Doses of Allopurinol
Study type Interventional
Id info nct alias
Completion date July 2016
Verification date July 2016
Why stopped
Id info org study id RDEA594-203
Required header url
Study design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Source Ardea Biosciences, Inc.
Primary completion date January 2011
Brief summary
Number of groups
Required header download date processed this data on September 07, 2016
Phase Phase 2
Start date October 2009
Has expanded access No
Biospec descr
Detailed description
Condition browse None
Intervention browse 30e527dab2a52cdbd2e7dfca52eb0dd1
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group 49b8e5b1cb399f36bb160d0f3409d520
Oversight info Canada: Health Canada (Oversight_info)
Eligibility bdd8471e378d71f4c6afa880a4eb8ca4
Keywords None
Conditions Gout
Locations 0f9c27f4894dcf1650b505f7470efb99, 1b7801df311fdc2ed72eee563043d47b, 1d101757bd2caf553a2e63ad98514d26 More →
Links None
Results references None
Arm groups RDEA594 600 mg qd (Arm Group), RDEA594 200 mg qd (Arm Group), RDEA594 200 mg, 400 mg qd (Arm Group), Matching Placebo (Arm Group)
Location countries Canada, Georgia, Poland, Spain, Ukraine, United Kingdom, United States
Interventions Placebo (Intervention), RDEA594 (Intervention), Allopurinol (Intervention)
Secondary outcomes 028b45d10a39efe321f589a5cc564f3b, 2e77b4a7980a07e19d8815d99c39f8ff, 4c096a29833e0b5eb990a498f517f36b, 5d2c29c39dacd58ac952cf7228ce35bb, b49dee6dfa70d486ae106de4b08a5997, bea6991d09e89889bcc99287389e2350, c0852f45958fe30f3a876a0f437a822b
References None
Primary outcomes de70603d841cb587e902e43ef2af3f43
Removed countries None
Overall officials d2db120dbe46f4116ac503f9304a4f9a